OPPOSE HB 1316: Pneumococcal Vaccine
and Hepatitis A Vaccine Mandate
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to the Texas Senate (info on vaccine injures, Hep A vaccine and pneumococcal
- MANDATED PNEUMOCOCCAL VACCINE
WOULD INVOKE MANDATED INSURANCE COVERAGE LEADING TO HIGHER INSURANCE PRICES
AND LOST COVERAGE FOR BASIC HEALTH CARE
Texas statutes require that if a vaccine is mandated for use by law that
a health benefit plan must provide coverage.1 It has been well
studied that state health insurance mandates drive up the cost of policies
and increase the number of uninsured.2 Texas already leads the
nation in the number of residents without health insurance coverage.
According to a recent study by the National Academy of Sciences, 28.4
percent of the state's population is already uninsured, and most of them are
working families.3 Higher costs will force even more people to
drop insurance - a Congressional Budget Office study estimates that for
every one percent increase in premiums, 200,000 Americans lose their
insurance. 3 The last thing families in Texas need is another
insurance mandate, and forcing the use of this vaccine by law is a sneaky
way of forcing an insurance mandate without using those words in the bill.
One insurance company we spoke with (Golden Rule) said their chief actuary
estimated that if this bill passes, they will have to raise family premiums
over $100 per year per child in Texas. All of the other vaccine mandates in
Texas put together cost families about $114 per year per child. This
mandate would effectually double the cost of premiums for vaccine coverage.
- VACCINE MANDATE NOT NEEDED -
PNEUMOCOCCAL VACCINE ALREADY HIGHLY RECOMMENDED AND ACCESSIBLE TO ALL
According to a study published in the American Academy of Pediatrics'
own journal, 99% of pediatricians already recommend PCV7 for children
younger than 2 years old4, so clearly pediatricians don't need a
mandate in place to alter their behavior to encourage the use of this
Additionally, this vaccine is already available to every child in the state
if the parent wants their child to have it. Many private insurance
companies already cover this vaccine voluntarily5, and families
certainly have the option to shop around and purchase higher priced policies
with coverage if that is desired. Of course we've never met a doctor who
has turned down cash as payment, but for those families who either can't
afford it or whose insurance plans don't cover it, they can go to any one of
over 6000 providers in the Texas Vaccines For Children Program (TVFC) and
receive the vaccine for free6 (purchased and distributed by the
federal government using our tax dollars) or to any one of the 3005
of the Texas based Federally Qualified Health Centers or Rural Health
Clinics through the federal Vaccines for Children Program.7 Only
the children who are underinsured (who have insurance but their insurance
doesn't cover PCV7) are inconvenienced with having to go to a Federal Health
Center or Clinic to receive their free shot, and according to the Department
of State Health Services, of the 750,000 children in day care, only 4% if
them are underinsured and would have to go to a Federal Health Center or
Clinic to receive their free shot.5
It all boils down to this: all of this nonsense about presumably needing a
mandate is to force the insurance companies of 4% of the kids in day care to
pay for this vaccine so the parents don't have to be inconvenienced to go to
a federal clinic where they can get it for free.
- PNEUMOCOCCAL VACCINE TOO
EXPENSIVE AND NOT COST EFFECTIVE - VACCEINE MANDATE WOULD GENERATE WINDFALL
FOR DOCTORS AND SINGLE MANUFACTURER
According to the Centers for Disease Control's (CDC's) price list,
pneumococcal vaccine is one of the most expensive childhood vaccines on the
market where the cost to give a child all four proposed required doses costs
almost as much as all the other infant vaccines combined. The federal bulk
purchase price through the Vaccines for Children Program is $51.58 per dose
($206.32 for the series)and the private sector wholesale cost
per dose is $65.958 ($275.80 for the series).
According to a study funded by the vaccine manufacturer itself on behalf of
the CDC, this vaccine is ineffectual from a cost savings perspective. This
is the first vaccine where the manufacturer's list price does not result in
a cost savings to society (the cost in terms of vaccine development and
distribution versus the cost of lives saved and mitigating illness). The
break-even price of PCV7 is reported to be $46 per dose from the societal
perspective and $18 per dose from the health care payer's perspective9
- far lower than the actual list prices of $51.58 and $65.95
respectively. When you couple this information with the impact on health
insurance premiums and availability, mandates for its usage don't make
financial or medical sense.
We called some pediatricians and found that in the private sector in Austin,
Texas, they are charging $132 per dose - DOUBLE their wholesale cost and a
whopping $528 for the series - and then they add on top of that a $25
administration fee each of the 4 times the shot is given.
You don't have to be a whiz with numbers to see why a pediatrician would
rather force insurance companies to pay for the vaccine when they can make a
profit of 66 dollars a dose times four doses rather than simply
administering a vaccine distributed and paid for by the Vaccines for
Children program. It is also important to note that there is only one
manufacturer, Wyeth Pharmaceuticals, of this PCV7 vaccine called Prevnar,
and this mandate would be nothing short of a windfall for pediatricians and
The costs may continue to climb long after this bill is passed because of
its open ended language requiring pneumococcal vaccines. The CDC states that
additional pneumococcal conjugate vaccines containing 9 and 11 serotypes are
being developed.16 This language requires any of these vaccines
to be automatically mandated when they are available potentially costing
even more money.
Flawed Clinical Trials Did Not Prove
Safety - MANDATES WILL COST MORE THAN MONEY
In the trials for this vaccine, Wyeth and Kaiser Permanente compared one
experimental vaccine (pneumococcal) against another experimental vaccine
(meningococcal), which seriously compromised the scientific validity of the
trial. Children in groups who got the pneumococcal vaccine suffered more
seizures, irritability, high fevers and other reactions. There were 12
deaths in the Prevnar group, including 5 Sudden Infant Death Syndrome (SIDS)
Since the PCV7 vaccine was licensed in 2000, there have been 9,040
PCV7-related adverse events reported to the federal government (VAERS),
including 1081 hospitalizations and 286 deaths.11
Each 0.5ml dose of Prevnar contains 0.125 mg. of aluminum10,
a metal that the American Academy of Pediatrics admits is neurotoxic to
humans.12 Federal regulations state: "The amount of aluminum in
the recommended individual dose of a biological product shall not exceed
1.250mg" 13 The problem is that multiple vaccines containing
aluminum are given on the same day. DTaP, HepB, Hib, and Prevnar, all
contain aluminum, and when the vaccines are given on the same day as what
typically happens, infants receive up to 1.475mg of aluminum, exceeding the
maximum dose. Aluminum is eliminated from the body primarily through the
kidneys. Infant kidney function (glomerular filtration rate) is low at
birth and doesn't reach full capacity until 1-2 years of age. Therefore
infants may not be able to effectively excrete aluminum in this and other
vaccines, contributing to heavy metal toxicity.14,15
Also, the vaccine manufacturer's product insert states that "Prevnar
has not been evaluated for any carcinogenic or mutagenic potential, or
impairment of fertility."10
Disease NOT SERIOUS ENOUGH THREAT TO
ENOUGH CHILDREN TO JUSTIFY MANDATE
There are 90 known
serotypes of Streptococcus Pnuemoniae bacteria - the PCV7 vaccine only
covers seven strains (the seven most antibiotic resistant strains)17.
In other words, the same doctors who overperscribed antibiotics causing
antibiotic resistance are now asking legislators to mandate the overuse of
another product bringing about another new set of consequences.
Additionally, the CDC explains that pneumococci bacteria are common
inhabitants in up to 70% of normal adults. This is not a bacteria that
normally makes people sick. It is common in the people we are around
everyday. The immunologic mechanism that allows disease to occur in some is
not clearly understood, however, disease most often occurs when a
predisposing condition exists, particularly pulmonary disease.16
According to the CDC, prior to the introduction of the PCV7 vaccine, the
number of children affected by pneumococcal disease in the whole United
States was 13,000 cases of bacteremia, 700 cases of meningitis, and 200
children died.16 Vaccine mandate proponents like to cite that
there were over 5 million cases of ear infections, but the vaccine was shown
no more than 7% effective against ear infections10. If you
consider that only a small percentage of these cases were in Texas, and only
a fraction of these children are in day care, and that the CDC reported that
in 2003, 60% of Texas children had already voluntarily received 3 or more
doses of PCV7 vaccine18, you simply can't justify a case to force
the vaccine by law.
- WHERE DO YOU DRAW THE LINE?
At what point is enough enough? With over 200 vaccines in the
development pipeline, legislators are going to have to show some restraint
over which vaccines are forced for use by law and which ones we are all
forced to pay for. Our bodies and our wallets won't be able to survive
- Texas Statutes: Insurance Code
§1367.053 (a) (2).
- Council for Affordable Health
Insurance: Health Insurance Mandates in the States - 2005.
- Institute of Medicine Report -
Insuring America's Health: Principles and Recommendations, p 167.
- Abstract for "Influence of
insurance status and vaccine cost on physicians' administration of
pneumococcal conjugate vaccine" published in Pediatrics. 2003 Sep;112(3 Pt
- Phone conversation with Casey
Blass, Department of State Health Services, Immunizations on 3/28/05.
- CDC Vaccine Price List Updated
- Lieu TA, Ray GT, Black SB, Butler
JC, Klein JO, Breiman RF, et al. Projected cost-effectiveness of
pneumococcal conjugate vaccination of healthy infants and young children.
- Manufacturer's Product Insert for
- FDA and CDC's Vaccine Adverse Event
Reporting System (VAERS) Data through 2004.
- Aluminum Toxicity in Infants and
Children (RE9607), Pediatrics Volume 97, Number 3 March, 1996, pp.
- 21CFR Title 21. Vol 7. Sec. 610.15.
- Simmer, K. Aluminium in Infancy.
In: Zatta PF, Alfrey AC. (Eds) Aluminium Toxicity in Infants' Health and
Disease. 1997, World Scientific Publishing.
- Unspoken Risks: The Impact of Mass
Vaccination on our Future, Sherri J. Tenpenny, DO. Presented to the
American Chriropractic Association in July, 2004.
- Epidemiology and Prevention of
Vaccine-Preventable Diseases, Eigth Edition, January 2004, The Department of
Health and Human Services Centers for Disease Control and Prevention.
- Butler JC, Hoffman J, Cetron MS, et
al. The continued emergence of drug-resistant Streptococcus pneumoniae in
the United States. An Update from the Centers for Disease Control
and Prevention's Pneumococcal Sentinel Surveillance System. J Infect Dis.
- U.S., National Immunization
Survey 2003. http://www.cdc.gov/nip/coverage/nis/03/tab03_antigen_state.xls